Bupredine Multidose 0.3 mg/ml Solution for Injection for Dogs, Cats and Horses

In horses, when used as directed in conjunction with sedatives or tranquillisers,
excitation is minimal but ataxia may occasionally be marked. Buprenorphine may
reduce gastrointestinal motility in horses but colic is rarely reported.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Pregnancy:
Laboratory studies in rats have not produced any evidence of a teratogenic effects.
However, these studies have shown post-implantation losses and early foetal deaths.
As reproductive toxicity studies have not been conducted in the target species, use
only according to the benefit/risk assessment by the responsible veterinarian.
The product should not be used pre-operatively in cases of Caesarean section, due
to the risk of respiratory depression in the offspring periparturiently, and should only
be used post-operatively with special care (see below).
Lactation:
Studies in lactating rats have shown that, after intramuscular administration of
buprenorphine, concentrations of unchanged buprenorphine in the milk equalled or
exceeded that in the plasma. As it is likely that buprenorphine will be excreted in the
milk of other species, use is not recommended during lactation. Use only accordingly
to benefit/risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
Buprenorphine may cause some drowsiness, which may be potentiated by other
centrally-acting agents, including tranquillisers, sedatives and hypnotics.
There is evidence in humans to indicate that therapeutic doses of buprenorphine do
not reduce the analgesic efficacy of standard doses of an opioid agonist, and that
when buprenorphine is employed within the normal therapeutic range, standard
doses of opioid agonist may be administered before the effects of the former have
ended without compromising analgesia. However, it is recommended that
buprenorphine is not used in conjunction with morphine or other opioid-type
analgesics, e.g. etorphine, fentanyl, pethidine, methadone, papaveretum or
butorphanol.
Buprenorphine has been used with acepromazine, alphaxalone/alphadalone,
atropine, detomidine, dexmedetomidine, halothane, isoflurane, ketamine,
medetomidine, propofol, romifidine, sevoflurane, thiopentone and xylazine.
When used in combination with sedatives, depressive effects on heart rate and
respiration may be augmented.

Revised: February 2022
AN: 00246/2020 & 00324/2021
4.9 Amounts to be administered and administration route
Species and
route
Post-Operative Analgesia
Potentiation of
Sedative EffectsDog:
Intramuscular or
intravenous
injection
10 - 20 μg/kg*
per 10 kg) repeated if necessary after
3 - 4 hours with 10 μg/kg or 5 - 6
hours with 20 μg/kg doses
10 - 20 μg/kg
(0.3 - 0.6 ml product per
10 kg)
Cat:
Intramuscular or
intravenous
injection
10 - 20 μg/kg
10 kg) repeated once if necessary
after 1 – 2 hours
--Horse:
Intravenous
injection
10 μg/kg
5 minutes after administration of an iv
sedative. The dose may be repeated
once, if necessary, after not less than
1-2 hours, in combination with
intravenous sedation.
5 μg/kg (1.7 ml product
per 100 kg) 5 minutes
after administration of
an iv sedative, repeated
if necessary after 10
minutes.
*) The dosages expressed in
hydrochloride). The kg in the table refers to body weight.
When used in horses, an intravenous sedative must be administered within five
minutes prior to injection of buprenorphine.
In dogs, sedative effects are present by 15 minutes after administration.
Analgesic activity may not develop fully until 30 minutes. To ensure that analgesia is
present during surgery and immediately on recovery, the product should be
administered preoperatively as part of premedication. When administered for
potentiation of sedation or as part of premedication, the dose of other centrally-acting
agents, such as acepromazine or medetomidine, should be reduced. The reduction
will depend on the degree of sedation required, the individual animal, the type of
other agents included in premedication and how anaesthesia is to be induced and
maintained. It may also be possible to reduce the amount of inhalational anaesthetic
used.
Animals administered opioids possessing sedative and analgesic properties may
show variable responses. Therefore, the response of individual animals should be
monitored and subsequent doses should be adjusted accordingly. In some cases,
repeat doses may fail to provide additional analgesia. In these cases, consideration
should be given to using a suitable injectable NSAID.
An appropriately graduated syringe must be used to allow accurate dosing.
The closure must not be punctured more than 100 times (with a 21G or 23G needle).
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In cases of overdosage, supportive measures should be instituted, and, if
appropriate, naloxone or respiratory stimulants may be used.
When administered at overdose to dogs, buprenorphine may cause lethargy. At very
high doses, bradycardia and miosis may be observed.

Revised: February 2022
AN: 00246/2020 & 00324/2021
Studies in horses where buprenorphine has been administered with sedatives have
shown very few side effects at up to five times the recommended dosage, but when
administered on its own it can cause excitement.
When used to provide analgesia in horses, sedation is rarely seen, but may occur at
dose levels higher than those recommended.
Naloxone may be of benefit in reversing reduced respiratory rate.
In toxicological studies of buprenorphine hydrochloride in dogs, biliary hyperplasia
was observed after oral administration for one year at dose levels of 3.5 mg/kg/day
and above. Biliary hyperplasia was not observed following daily intramuscular
injection of dose levels up to 2.5 mg/kg/day for 3 months. This is well in excess of
any clinical dose regimen in the dog.
Please also refer to Sections 4.5 and 4.6 of this SPC.
4.11 Withdrawal period
The product is not authorised for use in horses intended for human consumption.
5.